|By PR Newswire||
|November 27, 2012 08:01 AM EST||
- First publication of the global Phase III CORRECT and GRID study data of the oral multi-kinase inhibitor regorafenib
TORONTO, Nov. 27, 2012 /CNW/ - Bayer HealthCare today announced that the results of two pivotal Phase III studies for regorafenib were published online in the journal The Lancet ahead of a future print publication. Data from the CORRECT (Metastatic Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) and GRID (GIST - Regorafenib In Progressive Disease) trials provide robust evidence for the efficacy of regorafenib in patients with metastatic colorectal cancer (mCRC) or gastrointestinal stromal tumor (GIST) who have exhausted all other treatment options.
"The publication of the CORRECT and GRID trials in The Lancet signifies the potential of regorafenib as a new and effective treatment option for both mCRC and GIST, where there is a high unmet need," said Dr. Shurjeel Choudhri, Vice President, Medical and Scientific Affairs. "Bayer is dedicated to developing innovative therapies to improve patient's lives and we will continue to expand our oncology portfolio to make a difference for patients and physicians."
In the Phase III CORRECT trial regorafenib plus best supportive care (BSC) significantly improved overall survival (OS) (HR=0.77, 1-sided p-value=0.0052) and progression-free survival (PFS) (HR=0.49, 1-sided p-value <0.000001) compared to placebo plus BSC in patients with mCRC whose disease had progressed after approved standard therapies. In the study, median OS was 6.4 months with regorafenib versus 5.0 months with placebo; median PFS was 1.9 months with regorafenib versus 1.7 months with placebo. The data also showed a survival benefit in the regorafenib arm across nearly all subgroups analyzed, including no significant difference between patients with KRAS wild-type tumor and those with KRAS mutant tumor. No difference in overall response rate was observed.
"Although there has been progress in the treatment of metastatic colorectal cancer, drug resistance remains a huge challenge," says Dr. Christine Cripps, Professor of Medicine University of Ottawa Cancer Centre. "Regorafenib is a unique oral multi-kinase inhibitor that has the potential to become a new standard of care in mCRC and provides hope for those patients who until now would have had no further options."
The most common grade 3+ adverse events (≥5% of patients) were hand-foot skin reaction (16.6% vs. 0.4%), fatigue (15.0% vs. 8.3%), diarrhea (8.2% vs. 2.0%), hypertension (7.6% vs. 0.8%), and rash/desquamation (5.8% vs 0.4%). Quality of life was not adversely affected by regorafenib. The most serious adverse drug reactions in patients receiving regorafenib were severe liver injury, hemorrhage and gastrointestinal perforation.
The Phase III GRID trial, also published in The Lancet, showed that regorafenib plus BSC significantly improved PFS compared to placebo plus BSC (HR=0.27, p<0.000001) in patients with metastatic and/or unresectable GIST who were previously treated with imatinib and sunitinib, which means a 73% reduction in the risk of progression or death. The median PFS was 4.8 months in the regorafenib arm versus 0.9 months in the placebo arm. In addition, there was a positive trend in the regorafenib group in improving OS (HR=0.772, p=0.199); however, the OS did not reach statistical significance which was expected due to the cross-over design of the trial that allowed patients receiving placebo to receive regorafenib following disease progression.
Furthermore, a significantly greater disease control rate (DCR) was observed with regorafenib plus BSC compared to placebo plus BSC (52.6% vs. 9.1%; p<0.000001), DCR was defined as rate of complete response [CR] plus partial response [PR] plus durable stable disease [SD] maintained for at least 12 weeks. In addition, regorafenib demonstrated therapeutic benefit independent of prior treatment options based on analysis in pre specified subgroups that showed regorafenib had a statistically significant PFS benefit over placebo for patients receiving regorafenib as a third- or fourth-line treatment.
The most common grade 3 regorafenib-related adverse events which had higher incidence (≥5% ) in the regorafenib plus BSC vs placebo plus BSC were hypertension (27.3% vs 4.5%), hand-foot skin reaction (20.5% vs 0%), and diarrhea (7.6% vs 0%%). Grade 4 AEs were reported at a similar incidence in the regorafenib plus BSC vs placebo plus BSC (6.8% vs 6.1%).
About the CORRECT Trial
The Phase III study CORRECT randomized 760 patients with mCRC whose disease had progressed after currently approved standard therapies to receive regorafenib plus BSC or placebo plus BSC at a 2:1 ratio. Treatment cycles consisted of 160 mg of regorafenib (or matching placebo) once daily for three weeks on / one week off plus BSC. The primary endpoint of this trial was OS. Secondary endpoints included PFS, objective tumor response rate and disease control rate. The safety and tolerability of the two treatment groups were also compared.
About the GRID Trial
GRID was a randomized, double-blind, placebo-controlled, multi-center, cross-over Phase III study of regorafenib for the treatment of GIST. It randomized 199 patients whose disease had progressed despite prior treatment with imatinib and sunitinib. Patients were randomized in a 2:1 ratio to receive either regorafenib (160 mg once daily, 3 weeks on/1 week off) plus BSC or placebo plus BSC to evaluate efficacy and safety. The primary endpoint of this trial was PFS, and secondary endpoints included OS, time to progression, disease control rate, tumor response rate, duration of response, and safety of regorafenib. Patients initially randomized to placebo were allowed to cross over to open-label regorafenib once the disease progressed, of which 85% of the patients from the placebo arm did cross over.
About Stivarga® (regorafenib)
Regorafenib is an oral multi-kinase inhibitor that inhibits various kinases that are involved in mechanisms associated with tumor growth and progression (oncogenesis), blood vessel development (angiogenesis), and the tumor microenvironment. In preclinical studies, Stivarga inhibits several angiogenic VEGF receptor tyrosine kinases (VEGFR1 and murine VEGFR2/3) that play a role in tumor neoangiogenesis (the growth of new blood vessels). It also inhibits various oncogenic and tumor microenvironment kinases including, KIT, RET, RAF-1, B-RAF, B-RAFV600E, PDGFR, and FGFR1, which individually and collectively impact upon tumor growth, formation of a stromal microenvironment and disease progression.
Regorafenib has been submitted to Health Canada for marketing approval for the treatment of metastatic CRC and GIST. Market authorization in Canada has not yet been obtained.
Regorafenib was approved by the U.S. Food and Drug Administration for the treatment of mCRC and is marketed as STIVARGA® and has received priority review for treatment in GIST. Bayer has also submitted for marketing approval of regorafenib for the treatment of metastatic CRC in the EU in May 2012. The NDA for regorafenib for the treatment of advanced CRC filed in Japan in July 2012 was granted priority review.
Stivarga is a Bayer compound developed by Bayer and jointly promoted by Bayer and Onyx in the U.S. In 2011, Bayer entered into an agreement with Onyx, under which Onyx receives a royalty on all future global net sales of Stivarga in oncology.
About Bayer Inc.
Bayer Inc. (Bayer) is a Canadian subsidiary of Bayer AG, an international research-based group with core businesses in health care, crop science and innovative materials. Headquartered in Toronto, Ontario, Bayer Inc. operates the Bayer Group's HealthCare and MaterialScience businesses in Canada. Bayer CropScience Inc., headquartered in Calgary, Alberta operates as a separate legal entity in Canada. Together, the companies play a vital role in improving the quality of life for Canadians - producing products that fight diseases, protecting crops and animals, and developing high-performance materials for applications in numerous areas of daily life. Canadian Bayer facilities include the Toronto headquarters and offices in Montréal and Calgary.
Bayer Inc. has approximately 800 employees across Canada and had sales of $808 million CDN in 2011. Globally, the Bayer Group had sales of over 36 billion Euro in 2011. Bayer Inc. invested approximately $13 million CDN in research and development in 2011. Worldwide, the Bayer Group spent the equivalent of over 2.9 billion Euro in 2011 in R&D. For more information, go to www.bayer.ca.
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
SOURCE Bayer Inc.
The 19th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Digital Transformation, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportuni...
Jul. 23, 2016 10:15 PM EDT Reads: 2,401
From wearable activity trackers to fantasy e-sports, data and technology are transforming the way athletes train for the game and fans engage with their teams. In his session at @ThingsExpo, will present key data findings from leading sports organizations San Francisco 49ers, Orlando Magic NBA team. By utilizing data analytics these sports orgs have recognized new revenue streams, doubled its fan base and streamlined costs at its stadiums. John Paul is the CEO and Founder of VenueNext. Prior ...
Jul. 23, 2016 09:30 PM EDT Reads: 1,936
A critical component of any IoT project is what to do with all the data being generated. This data needs to be captured, processed, structured, and stored in a way to facilitate different kinds of queries. Traditional data warehouse and analytical systems are mature technologies that can be used to handle certain kinds of queries, but they are not always well suited to many problems, particularly when there is a need for real-time insights.
Jul. 23, 2016 08:45 PM EDT Reads: 1,637
CenturyLink has announced that application server solutions from GENBAND are now available as part of CenturyLink’s Networx contracts. The General Services Administration (GSA)’s Networx program includes the largest telecommunications contract vehicles ever awarded by the federal government. CenturyLink recently secured an extension through spring 2020 of its offerings available to federal government agencies via GSA’s Networx Universal and Enterprise contracts. GENBAND’s EXPERiUS™ Application...
Jul. 23, 2016 08:30 PM EDT Reads: 1,764
"My role is working with customers, helping them go through this digital transformation. I spend a lot of time talking to banks, big industries, manufacturers working through how they are integrating and transforming their IT platforms and moving them forward," explained William Morrish, General Manager Product Sales at Interoute, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 23, 2016 08:30 PM EDT Reads: 2,010
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 19th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world and ThingsExpo Silicon Valley Call for Papers is now open.
Jul. 23, 2016 08:00 PM EDT Reads: 2,408
Big Data engines are powering a lot of service businesses right now. Data is collected from users from wearable technologies, web behaviors, purchase behavior as well as several arbitrary data points we’d never think of. The demand for faster and bigger engines to crunch and serve up the data to services is growing exponentially. You see a LOT of correlation between “Cloud” and “Big Data” but on Big Data and “Hybrid,” where hybrid hosting is the sanest approach to the Big Data Infrastructure pro...
Jul. 23, 2016 08:00 PM EDT Reads: 1,777
The IoT is changing the way enterprises conduct business. In his session at @ThingsExpo, Eric Hoffman, Vice President at EastBanc Technologies, discussed how businesses can gain an edge over competitors by empowering consumers to take control through IoT. He cited examples such as a Washington, D.C.-based sports club that leveraged IoT and the cloud to develop a comprehensive booking system. He also highlighted how IoT can revitalize and restore outdated business models, making them profitable ...
Jul. 23, 2016 07:15 PM EDT Reads: 1,863
We all know the latest numbers: Gartner, Inc. forecasts that 6.4 billion connected things will be in use worldwide in 2016, up 30 percent from last year, and will reach 20.8 billion by 2020. We're rapidly approaching a data production of 40 zettabytes a day – more than we can every physically store, and exabytes and yottabytes are just around the corner. For many that’s a good sign, as data has been proven to equal money – IF it’s ingested, integrated, and analyzed fast enough. Without real-ti...
Jul. 23, 2016 07:00 PM EDT Reads: 858
I wanted to gather all of my Internet of Things (IOT) blogs into a single blog (that I could later use with my University of San Francisco (USF) Big Data “MBA” course). However as I started to pull these blogs together, I realized that my IOT discussion lacked a vision; it lacked an end point towards which an organization could drive their IOT envisioning, proof of value, app dev, data engineering and data science efforts. And I think that the IOT end point is really quite simple…
Jul. 23, 2016 06:15 PM EDT Reads: 785
With 15% of enterprises adopting a hybrid IT strategy, you need to set a plan to integrate hybrid cloud throughout your infrastructure. In his session at 18th Cloud Expo, Steven Dreher, Director of Solutions Architecture at Green House Data, discussed how to plan for shifting resource requirements, overcome challenges, and implement hybrid IT alongside your existing data center assets. Highlights included anticipating workload, cost and resource calculations, integrating services on both sides...
Jul. 23, 2016 06:00 PM EDT Reads: 1,878
"We are a well-established player in the application life cycle management market and we also have a very strong version control product," stated Flint Brenton, CEO of CollabNet,, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 23, 2016 05:30 PM EDT Reads: 1,713
The IoT has the potential to create a renaissance of manufacturing in the US and elsewhere. In his session at 18th Cloud Expo, Florent Solt, CTO and chief architect of Netvibes, discussed how the expected exponential increase in the amount of data that will be processed, transported, stored, and accessed means there will be a huge demand for smart technologies to deliver it. Florent Solt is the CTO and chief architect of Netvibes. Prior to joining Netvibes in 2007, he co-founded Rift Technologi...
Jul. 23, 2016 05:00 PM EDT Reads: 934
We're entering the post-smartphone era, where wearable gadgets from watches and fitness bands to glasses and health aids will power the next technological revolution. With mass adoption of wearable devices comes a new data ecosystem that must be protected. Wearables open new pathways that facilitate the tracking, sharing and storing of consumers’ personal health, location and daily activity data. Consumers have some idea of the data these devices capture, but most don’t realize how revealing and...
Jul. 23, 2016 04:00 PM EDT Reads: 1,974
Unless your company can spend a lot of money on new technology, re-engineering your environment and hiring a comprehensive cybersecurity team, you will most likely move to the cloud or seek external service partnerships. In his session at 18th Cloud Expo, Darren Guccione, CEO of Keeper Security, revealed what you need to know when it comes to encryption in the cloud.
Jul. 23, 2016 04:00 PM EDT Reads: 2,301
What are the successful IoT innovations from emerging markets? What are the unique challenges and opportunities from these markets? How did the constraints in connectivity among others lead to groundbreaking insights? In her session at @ThingsExpo, Carmen Feliciano, a Principal at AMDG, will answer all these questions and share how you can apply IoT best practices and frameworks from the emerging markets to your own business.
Jul. 23, 2016 03:45 PM EDT Reads: 1,505
Basho Technologies has announced the latest release of Basho Riak TS, version 1.3. Riak TS is an enterprise-grade NoSQL database optimized for Internet of Things (IoT). The open source version enables developers to download the software for free and use it in production as well as make contributions to the code and develop applications around Riak TS. Enhancements to Riak TS make it quick, easy and cost-effective to spin up an instance to test new ideas and build IoT applications. In addition to...
Jul. 23, 2016 03:30 PM EDT Reads: 1,838
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
Jul. 23, 2016 03:15 PM EDT Reads: 816
Extracting business value from Internet of Things (IoT) data doesn’t happen overnight. There are several requirements that must be satisfied, including IoT device enablement, data analysis, real-time detection of complex events and automated orchestration of actions. Unfortunately, too many companies fall short in achieving their business goals by implementing incomplete solutions or not focusing on tangible use cases. In his general session at @ThingsExpo, Dave McCarthy, Director of Products...
Jul. 23, 2016 03:00 PM EDT Reads: 1,652
Ask someone to architect an Internet of Things (IoT) solution and you are guaranteed to see a reference to the cloud. This would lead you to believe that IoT requires the cloud to exist. However, there are many IoT use cases where the cloud is not feasible or desirable. In his session at @ThingsExpo, Dave McCarthy, Director of Products at Bsquare Corporation, will discuss the strategies that exist to extend intelligence directly to IoT devices and sensors, freeing them from the constraints of ...
Jul. 23, 2016 02:30 PM EDT Reads: 1,702